FINAL ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is responsive to the Amendment and Reply filed 10 April 2026. Claims 24-26 and 33-35 have been amended, and claims 24-35 and 37-43 remain under consideration. Applicant’s amendments and arguments have been thoroughly reviewed, and have overcome the following objections/rejections set forth in the prior Office action:
The rejections of claims under 35 USC 112(b)/second paragraph (although it is noted that the amended claims are indefinite for the reasons given below); and
The rejection of claims under 35 USC 101, in view of the amendment of independent claim 24 such that it no longer recites an abstract idea.
Claims 24-35 and 37-43 remain rejected for the reasons given below, which include new grounds of rejection necessitated by Applicant’s amendment. Any rejections and/or objections not reiterated in this action have been withdrawn. This action is FINAL.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 112(b)/second paragraph
THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT'S AMENDMENTS:
Claims 24-35 and 37-43 remain rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 24-35 and 37-43 are indefinite over the recitation in independent claim 24 of the limitation “sequencing genomic DNA and genotyping at least 10,000 LOH loci in the genomic DNA as having a heterozygous or homozygous genotype from at least one pair of human chromosomes in the genomic DNA”. It is noted that the claim previously referred to one activity (genotyping….using DNA sequencing) that was performed with regard to “at least one pair of human chromosomes…”; however, the claims as amended now recites two activities, “sequencing….and genotyping”. Based on the present wording of the claim, it is not clear whether the further limitation “…from at least one pair of human chromosomes…” limits/modifies only the “genotyping” of the claim or both the “sequencing” and the “genotyping”, and as the limitation “at least one pair of human chromosomes…” is at least potentially further limited by subsequent claim language (as discussed in the rejection immediately below), further clarification is needed to ensure that the boundaries of the “sequencing….and genotyping” as recited in amended claim 24 are clear and definite.
Claims 24-35 and 37-43 are indefinite over the recitation in independent claim 24 of the limitation “wherein LOH loci from a human X/Y sex chromosome pair and human chromosome 17 are excluded”, because it is not clear to what this exclusion applies. More particularly, there are multiple prior references in the claims to LOH loci, and the present claim language does not make sufficiently clear what prior elements of the claim are being further limited. Claim 24 recites “sequencing genomic DNA and genotyping at least 10,000 LOH loci in the genomic DNA as having a heterozygous or homozygous genotype from at least one pair of human chromosomes in the genomic DNA”, and also states that “the genomic DNA comprises at least one” LOH region “wherein the at least one LOH region comprises one or more LOH loci having a homozygous genotype”; thus, there are multiple activities/characteristics referenced in the claim, with regard to which the limitation “LOH loci from a human X/Y sex chromosome pair and human chromosome 17 are excluded” may (or may not) apply. Further clarification is therefore needed to ensure that the boundaries of the claims are clear.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT'S AMENDMENTS:
Claims 24-35 and 37-43 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of copending Application No. 19/088,442 (correspond to US 20250250643A1 [previously cited]). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Instant independent claim 24 as amended is drawn to a method comprising “sequencing genomic DNA and genotyping at least 10,000 LOH loci in the genomic DNA as having a heterozygous or homozygous genotype from at least one pair of human chromosomes in the genomic DNA”, wherein “the genomic DNA comprises at least one loss of heterozygosity (LOH) region”, the “at least one LOH region comprises one or more LOH loci having a homozygous genotype”, “LOH loci from a human X/Y sex chromosome pair and human chromosome 17 are excluded”, and “the at least one LOH region is longer than 5 megabases but shorter than the length of the whole chromosome containing the at least one LOH region”. The ‘442 claims, and particularly claim 13 and claims dependent therefrom, are directed to methods comprising “sequencing genomic DNA from a cancer cell” to produce sequencing results, and “genotyping at least 1,000 loci in the DNA sequencing results as having a heterozygous or homozygous genotype, wherein the loci are not in a human X/Y sex chromosome pair”, wherein “the genomic DNA comprising a homozygous genotype comprises an indicator loss of heterozygosity (LOH) region” and “the indicator LOH region is longer than 1.5 megabases but shorter than the length of the whole chromosome containing the indicator LOH region”. The two sets of claims thus embrace the same general activities of sequencing genomic DNA followed by genotyping that DNA to establish a heterozygous and/or homozygous genotype, and thereby identifying indicator LOH regions.
While the ‘442 claims differ from instant independent claim 24 in some respects, it is noted that the ‘442 dependent claims recite the preferred minimum LOH region length of instant claim 24 (see, e.g., ‘442 claim 14), as well as the exclusion of chromosome 17 now recited in instant claim 24 (see, e.g., ‘442 claim 25). The ‘442 claims also recite cancer cell types corresponding to the preferred cell types of the instant claims (see, e.g., instant dependent claims 30-31 and 37-43), and otherwise set forth preferred embodiments that mirror those of the instant claims with regard to LOH region length, chromosome pair numbers, etc. While instant claim requires genotyping ‘at least 10,000 LOH loci”, which differs from the maximum number of loci specified in the ‘442 claims (of “at least 1,000 loci”; see ‘442 claim 13), an ordinary artisan would have recognized that “at least 1,000 loci” embraces embodiments including any number of loci larger than 1,000, including “at least 10,000 loci” as set forth in the instant claims, and further that the type of sequencing recited in the ‘442 claims would embrace generation of sequencing data including information regarding such larger numbers of loci. Thus, this difference does not render the instant claims patentably distinct from the ‘442 claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The Reply of 10 April 2026 traverses the rejection on the grounds that “the claims of the ‘442 Application recite a detecting step, and the present claims do not” (Reply page 6); Applicant thus urges that the grant of the present claims “would not unjustly extend the rights” encompassed by the reference claims because “the present claims do not recite the same features of the reference case” (Reply page 6).
These arguments have been thoroughly considered but are not persuasive because the claims presently pending the ‘442 application do in fact recite the activity of sequencing followed by genotyping, as discussed above (it is noted that the ‘442 claims were amended subsequent to the filing of the Reply in the instant case, with Applicant’s arguments appear to reference and rely on a prior claim set in the ‘442 application). Thus, the current rejection is proper, as it relies on the current language of the claims (with the amendment of instant independent claim 24 necessitating new grounds), and because the instant claims are not patentably distinct from the ‘442 claims (again for the reasons set forth above).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANA B JOHANNSEN whose telephone number is (571)272-0744. The examiner can normally be reached Monday-Friday, 7:30 am-3:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached at (571) 272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIANA B JOHANNSEN/Primary Examiner, Art Unit 1682
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